Clinical – Biostatical Submissions

Tata Consultancy Services; Delhi; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Tata Consultancy Services (TCS) Life Sciences is seeking an experienced leader for Clinical – Standards and Digital Data Flow. The role requires hands-on expertise in clinical data standards, data flow, metadata repositories, and regulatory submissions, with strong communication and cross-pharma networking.

The candidate will co-lead roadmaps, contribute to differentiated product offerings, and represent TCS in industry forums while supporting business development and client advisory activities.

Qualifications

• Must have global drug development experience in Digital Data Flow and clinical data standards.
• Hands-on with EDC, SDTM/ADaM, and regulatory submission packages.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Co-lead global strategy and roadmap for Clinical Standards and Digital Data Flow.
• Drive design and development of solutions from a business perspective.
• Represent TCS at industry consortia and lead external visibility.

Skills

Clinical Standards

Digital Data Flow

Metadata Repository

Biometrics

Data Management

EDC

non-CRF

TFLs

SDR

USDM

Communication skills

Education

Master’s degree in sciences

PhD is an advantage

Job description

We are Hiring for Clinical – Biostatical Submissions (Domain SME)

Experience: 10 to 15 years only

Then this function of Clinical – Standards and Digital Data Flow Leader at Tata Consultancy Services (TCS) Life Sciences (LS) might an excellent opportunity. We are looking for an experienced & inspiring pharma leader with hands-on expertise in Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management (EDC, non-CRF), TFLs, SDR, USDM within-depth insights in needs, challenges and innovative trends in these domains at a global level. Outstanding communciation skills with ability to translate technology in a clear & easy-to-understand language and cross-pharma senior management network are fundamental to this role.

Main responsibilities and duties

• Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends.
• Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product.
• Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.)
• Co-leads the design & development for these solutions from a business view
• Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards and represents TCS at consortia (e.g. CDISC)
• Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.

Qualifications and education

• Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage
• At least 6 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs)
• Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation.
• Experience in applying AI in standardization, SDTM, ADaM and TFL generation.
• Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM
• Experience in innovative ways to automate testing and validation
• Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners.
• Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI)
• Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language
• Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.